UNITED STATES – Additional lots of the drug losartan have been recalled duee to the presence of a potentially carcinogenic substance in the medication. The recall was initiated voluntarily by the drug manufacturer, Teva Pharmaceuticals USA Inc., and has now been expanded to include six new lots of the drug.
The U.S. Food and Drug Administration announced the updated losartan recall on June 11 and stated that it has been expanded to include six new lots. This includes four lots of 100 mg losartan potassium and two lots of 50 mg losartan potassium that are believed to contain N-Nitroro-N-methyl-4-aminobutyric acid (NMBA).
NMBA is a potentially carcinogenic (cancer-causing) substance that the FDA does not allow in pharmaceutical products above a certain amount. Teva detected levels of NMBA beyond the FDA’s set limit in a lot of losartan’s active ingredient made at Hetero Labs. The lots were then used to make six bulk lots of losartan potassium tablets, which are prescribed for treatment of high blood pressure, among other medical conditions.
The FDA says that the six bulk lots were sold to Golden State Medical Supply and then resold to retailers under a Golden State Medical Supply label. The bottles sold to patients contained quantities of 30 pills, 90 pills, or 1,000 pills. The FDA posted a description of the affected pills, as well as all of the lots numbers included in the recall on its website.
The FDA has advised against discontinuation of the medication in affected patients. Patients taking recalled lots of losartan potassium should contact their doctors to discuss a new prescription, the FDA says.
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